GDUFA Research Outcomes
PBPK Models
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Physiologically-based Pharmacokinetic Model to Support Ophthalmic Suspension Product Development
Le Merdy, Maxime; Fan, Jianghong; Babiskin, Andrew; Zhao, Liang
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Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Levofloxacin Solution Case Study
Le Merdy, Maxime; Zheng, Yujuan; Lukacova, Viera; Tan, Ming Liang; Babiskin, Andrew; Zhao, Liang
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Physiologically-based Pharmacokinetic Model to Support Ophthalmic Suspension Product Development
LeMerdy, Maxime; Fan, Jianghong; Babiskin, Andrew; Zhao, Liang
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Application of Ocular Physiologically Based Pharmacokinetic Modeling to Understand the Impact of Particle Size and Viscosity on Ophthalmic Bioavailability of Tobradex ST Suspension in Rabbits
Lemerdy, Maxime; Tsakalozou, Eleftheria; Choi, Stephanie; Kim, Myongjin; Xu, Lin; Stewart, Sharron; Chockalingam, Ashok; Rouse, Rodney; Matta, Murali; Zhao, Liang; Lionberger, Robert; Fan, Jianghong
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Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Moxifloxacin Solution Case Study
Le Merdy, Maxime; Lukacova, Viera; Tan, Ming-Liang; Babiskin, Andrew; Zhao, Liang
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Impact of Changes in Ophthalmic Emulsion Globule Size Distribution and Viscosity on Tear Film Thickness and Menisci Characteristics
Kumar, Sandeep; Cook, Nicholas; Gum, Glenwood; Manza, Linda; Naageshwaran, Vatsala; Lyulkin, Mathew; Xu, Xiaoming; Patel, Deval; Qu, Haiou; Walenga, Ross; Tan, Ming Liang; Babiskin, Andrew; Kaisar, Mohmmad Abul
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How Spray Metric Variability Impacts the Initial Deposition of Nasal Sprays
Kolanjiyil, Arun; Hosseini, Sana; Alfaifi, Ali; Golshahi, Laleh; Hindle, Michael; Longest, Worth
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On the Importance of Liquid Motion in Nasal Spray Delivery
Kolanjiyil, A; Golshahi, L; Longest, W
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The Effect of PLGA Molecular Weight on Drug Release from Microspheres
Kohno, Moe; Andhariya, Janki; Rothstein, Sam; Wang, Yan; Qin, Bin; Burgess, Diane
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Effect of Spray Momentum on Nasal Spray Droplet Transport and Deposition
Kolanjiyil, Arun; Hosseini, Sana; Manniello, Michele; Alfaifi, Ali; Farkas, Dale; Golshahi, Laleh; Longest, Worth